Endoscopic I-scan Versus Histopathological Evaluation Of Esophageal Lesions

May 17, 2023 updated by: Michael Mokhtar Sadik, Sohag University

Considering esophageal diseases, according to a cross-sectional study of endoscopic findings in patients who underwent upper endoscopy at the Fayoum University Hospital, the most common esophageal conditions seen with the endoscope were esophageal varices (25.6% of cases), GERD (23.8% of cases), esophagitis (7.4% of cases), and esophageal monilasis.

GERD is characterized by dystressing symptoms and consequences brought on by the reflux of stomach contents. (Vakil et al., 2006)It appears that the 2 main GERD phenotypes have different pathophysiological and clinical characteristics. In addition, the response to antireflux medication varied significantly between NERD and erosive esophagitis. Patients with NERD made up the majority of the group with refractory heartburn because they had a noticeably lower response rate to proton pump inhibitor (PPI) therapy.

Barrett's oesophagus (BO) and oesophageal adenocarcinoma, may develop as a result of GERD. Barrett's oesophagus is characterised by intestinal metaplasia, which is characterised by acid mucin-containing goblet cells, and the replacement of any length of the squamous epithelium in the distal oesophagus by columnar epithelium.

Dysphagia is frequently brought on by esophageal cancer, which is a serious public health issue. In 2003, there were an estimated 13,900 new instances of esophageal cancer in the US, and 13,000 people passed away from the disease. Only 13% of people survive five years.

High-resolution white-light endoscopy during gastroscopy can identify abnormalities in the mucosa. The endoscopist must decide if the aetiology of erosions, ulcers, strictures, or metaplasia is non-neoplastic or cancerous if they are discovered. Discoloration, a grainy appearance (orange peel effect), and small lumps and depressions in Barrett's layer are indications of dysplasia.

The high-definition I-Scan was created by Pentax (HOYA, Japan) and is based on processing the picture captured by the endoscope's CCD (charge coupled device) to enhance the contrast of the vascular structures and the patterns of the digestive tract's mucosa.(Andrés Reyes-Dorantes, 2011)For the situations outlined below, some authors advise using the I-Scan modes:I-Scan 1 (SE) thought to be used to find lesions. Without affecting the clarity of the endoscopic image, it sharpens the image of minute surface defects,the I-Scan 2 (TE plus SE) imaging system should be utilized to characterize lesions. It increases subtle alterations in the mucosa and vascular architecture while combining surface and tone augmentation and for defining lesions, I-Scan 3 (TE plus CE) should be utilized. The margins of the endoscopic image are darkened and blue colour is digitally added.

In patients with gastrointestinal diseases, endoscopic biopsy and histological evaluation enable early diagnosis of precancerous and cancerous tumours and prompt disease therapy.(Afzal et al., 2006)The results of specimens from a study conducted over five years (2004-2008) in the pathology departments of Cairo University's faculty of medicine and the Theodor Bilharz Research Institute in Egypt were as follows: 54.76% of the 210 esophageal specimens had GERD, 17.61% had Barrett's oesophagus, 3.81% had benign lesions, 18.6% had malignant lesions (squamous cell carcinoma, adenocarcinoma, and undifferentiated carcinoma, each accounting for 10.48% of the total), and 5.24% had other conditions.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: El-zahraa M Megheizel, assistant professor

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag University Hospital
        • Contact:
          • Magdy M Amin, professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • : All patients with any gastro-esophageal symptoms who underwent upper endoscopy at the endoscopy unit of Tropical medicine and Gastroenterology department will be included.

Exclusion Criteria:

  • Any cirrhotic patient.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
detection of esophageal lesions
Time Frame: 12 months
comparison between number of lesions that could be detected by upper endoscopy and lesions detected by histopathological examination of taken biopsies
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

May 17, 2023

First Submitted That Met QC Criteria

May 17, 2023

First Posted (Actual)

May 25, 2023

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 17, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Soh-Med-23-05-05MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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